Kornimate/medical-research-clean huggingface dataset:
study of natriuretic peptide receptor 1 (npr1) antagonist in adult patients with postural orthostatic tachycardia syndrome (pots)

Conditions: Postural Orthostatic Tachycardia Syndrome (POTS)

Summary: this study is researching an experimental drug called regn7544 (called "study drug"). the study is focused on participants with pots. the aim of the study is to see how safe, tolerable, and effective the study drug is. the study is looking at several other research questions, including: * how the study drug changes heart rate and blood pressure in participants with pots * what side effects may happen from taking the study drug * how much study drug is in the blood at different times * whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)


Eligibility criteria:
key inclusion criteria: 1. is diagnosed with pots and demonstrates consensus criteria (a), (b), (c) and (d) below during screening: 1. increase in hr ≥30 beats per minute (bpm) within 10 minutes of changing from supine to a standing position, as described in the protocol 2. absence of orthostatic hypotension, defined as a decrease in systolic blood pressure (sbp) \>20 mm hg within 3 minutes of standing 3. absence of other conditions explaining orthostatic tachycardia in the judgment of the investigator, as defined in the protocol 4. ongoing episodic symptoms consistent with pots (for example, lightheadedness, palpitations, tremulousness, generalized weakness, blurred vision, and fatigue) that are worse with standing and are relieved by lying down and which have been present for ≥3 months 2. during screening, a participant must score ≥3 on the patient global impressions of severity (pgis) 3. has a body mass index between 18 and 35 kg/m2, inclusive key exclusion criteria: 1. history of hypertension or a seated sbp during screening that is \>140 mm hg 2. sbp during active stand (as) test during screening, either supine or standing, that is \>140 mm hg systolic on ≥2 measurements 3. increase in hr \<20 bpm within 10 minutes of changing from supine to a standing position, as defined in protocol 4. is judged by the investigator to have significant heart failure, cardiovascular disease, liver disease, or renal disease (ie, estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m2) based on medical history, physical exam, laboratory studies, and/or electrocardiogram (ecg) performed during screening period 5. is confined to bed more than 50% of waking hours 6. within 5 days of screening visit has used medications with direct effects on blood volume, bp, or hr (eg, midodrine, droxidopa, octreotide, clonidine, methyldopa, ivabradine, beta-blockers, calcium channel blockers, pyridostigmine, fludrocortisone, desmopressin, stimulants or intravenous (iv) saline) note: other protocol-defined inclusion/exclusion criteria apply

Keywords: orthostatic intolerance
epidemiological study on the surgical removal of third molars

Conditions: Impacted Third Molar Tooth

Summary: the aim of this study is to get a clear view on current practice of surgical third molar removal in belgium and the association with morbidity and complications. for this prospective cohort study, patients who visit the outpatient department of oral and maxillofacial surgery of the university hospitals leuven or hospitals affiliated with the flemish hospital network will be participating. all included patients are referred from primary dental providers for the surgical removal of one or more third molars. before participating, written informed consent will be recorded from all eligible subjects. patients consult one of the oral and maxillofacial surgeons or residents working on the department of the university hospitals leuven for the removal of third molars. in the standard procedure, patients are not routinely clinically monitored after one week at the department. pre-operative, operative and postoperative data will be collected through a questionnaire, extracted data from the patient's medical file and panoramic radiography. the surgeon's individual operation technique will be registered through a one-off questionnaire. the questionnaires are taken at the same time of consultation and includes a maximum of 8 questions per time and are considered as non-invasive and a minimal burden for the patient. postoperatively, patients record their recovery status and ability to resume daily- and work activities at day 3 and 10 by using a dairy system and, if necessary, revisit the outpatient department of oral and maxillofacial surgery.


Eligibility criteria:
inclusion criteria: * referred for the removal of one or more third molars exclusion criteria: * other concomitant oral procedures in the same surgical session
a phase 1 antiretroviral drug-drug interaction study in healthy volunteers (ddi)

Conditions: Infection, Human Immunodeficiency Virus

Summary: this is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. there is no formal hypothesis, however, it is expected that the coadministration of bms-663068 with darunavir (drv)/cobicistat (cobi) or cobi will increase the systemic exposure of bms-626529.


Eligibility criteria:
inclusion criteria: * healthy male and female * nonsmoking subjects * ages 18 to 50 years * inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive * women of childbearing potential * must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion exclusion criteria: * any history of acute or chronic medical and surgical illness. * personal of family history of hemophilia a or b * other protocol defined exclusion criteria could apply
atrial fibrillation and carotid atherosclerosis in ischemic stroke patients-(afcas)

Conditions: Ischemic Stroke; Atrial Fibrillation; Carotid Stenosis

Summary: the main aim of the study is to investigate the prevalence and characteristics of ischemic stroke patients with atrial fibrillation and concurrent carotid atherosclerosis. additionally, this study will investigate the effect of concurrent carotid atherosclerosis on the outcomes of recurrent stroke, myocardial infarction and death during follow-up


Eligibility criteria:
inclusion criteria: * hospitalization due to ischemic stroke * atrial fibrillation * αny type of carotid vascular imaging exclusion criteria: * intracerebral haemorrhage on admission * haemorrhagic transformation on admission

Keywords: ischemic stroke atrial fibrillation carotid stenosis atherosclerosis
oral versus intravenous rehydration for prevention of dehydration in premature babies, during the first days of life.

Conditions: Low Birth Weight Infant; Enteral Nutrition

Summary: this prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via iv (intravenous) infusion in premature infants of more than 32 weeks ga (gestational age) aims to determine whether administration of a hypo-osmolar oral hydration solution is as efficient as intravenous infusion.

in order to prevent dehydration of the premature infant during the first days of life, enteral nutrition with milk must be complemented by an additional fluid supply, commonly administered intravenously. we propose to perform a prospective randomised multi-centric study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via iv (intravenous) infusion in premature infants of more than 30 weeks ga (gestational age). we define success as a weight loss inferior to 15 % of birth weight and a weight at day 15 superior to birth weight. failure was defined hence as a weight loss superior to 15% of birth weight or a weight at day 15 inferior to birth weight or a severe complication or death. major violations of the protocol in the study group will be counted as failures. the other objectives were to determine whether oral hydration demonstrates practical advantages: less complications in initial management, more comfort for the baby and less technical challenges for the nurses/doctors in charge. furthermore to evaluate the clinical tolerance of oral hydration from a nutritional point of view and to examine it's effects on intestinal function (defecation, gastric residues), signs of intestinal inflammation and gi flora.

Eligibility criteria:
inclusion criteria: * premature babies between 32 to 34 + 6 weeks of gestation, with a birth weight greater than 1700g and less than 2200g under exclusion of sga (small for gestational age) babies with a bw \< 10th percentile. * infants must be included within the first 12 to 24 hours of life * good tolerance to nasogastric milk feeding * necessity of additional fluid supply * any suspicion of gastro intestinal or metabolic disease * maximal humidity in incubator * parental consent form exclusion criteria: * suspicion of gastro-intestinal disease, * severe digestive risks, and metabolic diseases in the family history, * metabolic or hydro-electrolyte disorders * other severe diseases

Keywords: preterm babies hydration oral rehydration solution continuous gastric drip fluid therapy premature babies comfort infant care technical challenge for the nurses/doctors in charge
bioavailability and metabolism of anthocyanins following acute cranberry consumption

Conditions: Bioavailability; Cardiovascular Disease

Summary: this study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be measured in blood and urine after a single acute consumption of cranberry juice.

little is known about the acute or chronic pharmacokinetics and metabolism of anthocyanins consumed in amounts relevant to usual dietary intakes. thus, we hypothesize that anthocyanins from a single oral dose of cranberry juice will be absorbed quickly and can be measured in the circulation and urine within 2-4 h. further, these anthocyanins will undergo a degree of metabolism but will circulate as well as be removed from blood as both parent compounds and metabolic products. this research proposal is submitted as an independent sub-study of an existing project, "effects of cranberry juice on endothelial function in patients with coronary artery disease", conducted by joseph a. vita, md at the boston university school of medicine and sponsored by ocean spray cranberries, inc. this study includes 15 subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically proven coronary artery disease who will receive a single dose of 480 ml cranberry juice. to test the hypotheses of the study to be conducted at hnrca tufts, we will utilize blood and urine samples that are already collected and stored. we will separate and analyze anthocyanins in these samples by hplc and determine the pharmacokinetics of relevant anthocyanins.

Eligibility criteria:
inclusion criteria: * stable cad patients * men \& postmenopausal women * aged 21-80 years * all ethnic groups * english language exclusion criteria: * subjects with heart failure are not eligible for participation in this study. * women with a positive urine beta hcg pregnancy test and lactating women or women who are planning to become pregnant. * clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate. * regular use of oral steroids * cigarette smoking and/or nicotine replacement use * regular daily intake of ≥ 2 alcoholic drinks * illicit drug use * history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study. * no dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission. * treatment with an investigational new drug within the last 30 days.
homeless care management app

Conditions: Substance Use Disorders; Mental Health Impairment; Health Behavior; Adherence, Patient

Summary: there is a significant revolving door of incarceration among homeless adults, a population with substantial health disparities. homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be re-incarcerated. the proposed study will use mobile technology to address these barriers and fill gaps in the understanding of the causes of the revolving door of homeless incarceration. this research represents a step toward integrated service connection and healthcare service provision for one of the most underserved, high need, and understudied populations in the united states. smart phone apps that increase the use of available healthcare services and identify predictors of key outcomes (e.g., homelessness, re-arrest, medication compliance) could be used to reach hard to reach populations with histories of significant and persistent health disparities (e.g., homeless adults).


Eligibility criteria:
inclusion criteria: * released from dallas county jail in the past month * plan to reside in the dallas area for the next year * enrolled in the bridge homeless recovery program * willing and able to attend the baseline visit, randomization visit, and the 1, 3, and 6-month follow-up visits * score ≥ 4 on the realm-sf indicating \> 6th grade english literacy level * score \>24 on the mini-mental state exam indicating no substantial cognitive impairment. exclusion criteria * cannot read english * under the age of 18

Keywords: case management homelessness smartphone health related quality of life mental health substance use disorders
assess diversity of gut microbiome in met nsclc in correlation to tx & adverse effects

Conditions: Non Small Cell Lung Cancer

Summary: this is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic non-small cell lung cancer (nsclc) while receiving treatment for nsclc.


Eligibility criteria:
inclusion criteria: * 1. advanced/metastatic non-small cell lung cancer nsclc patients. * 2. the patient himself/herself must be 18 years of age on day of signing informed consent. * 3. the subject has signed the informed consent form. * 4. the patient must be eligible to receive fda approved and non-approved pd1 inhibitors (i.e. pembrolizumab, nivolumab) or pdl1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive fda approved and non-approved tyrosine kinase inhibitors. * 5. the subject will be registered upon submission of the samples. when submitted on separate dates, the submission occurring later will be considered the date of registration exclusion criteria: * 1. those subjects who are determined clinically unstable of the participation of this study as determined by the pi or treating physician will be excluded and asked to focus on their treatment.
corticotomy-assisted class iii elastic applications

Conditions: Class III Malocclusion

Summary: this prospective randomized clinical study aimed to evaluate the effectiveness of corticotomy-assisted maxillary protraction with three different miniplate and intermaxillary elastic applications after corticotomy in patients with skeletal class iii malocclusion.

in acrylic splint group (as) and palatal miniscrew group (ms), an acrylic splint containing hooks in the upper molar region was prepared and cemented. in the ms group, two miniscrews were used in the palatal region for additional anchorage. an incomplete le fort 1 osteotomy was performed in all patients to free the maxilla. miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (mp). class iii elastics were applied 5 days after the surgery.

Eligibility criteria:
inclusion criteria: * skeletal class iii malocclusion * anb angle between 0 and -4° * normal or horizontal growth pattern * anterior crossbite or edge-to-edge incisor relationship * permanent dentition exclusion criteria: * requirement for maxillary expansion * pseudo-class iii malocclusion * inadequate oral hygiene * missing tooth in the upper dentition

Keywords: class iii malocclusion miniplates corticotomy skeletal anchorage class iii elastics
outcome of longterm antithrombotic therapy in acute coronary syndrome patients

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Summary: this observational study will based on the register of information and knowledge about swedish heart intensive care admissions (riks-hia) and the swedish coronary angiography and angioplasty registry (scaar) which since 2009 are merged into the swedish web-system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (swedeheart). the aim of this study is to investigate the impact of different antithrombotic treatment options (treatment duration, type of treatment and combination of treatments) in acute coronary syndrome (acs) patients on outcomes such as recurrent ischemic events and mortality.


Eligibility criteria:
inclusion criteria: * patient with an event of acs under the study period * patient found in the national registry of drug prescriptions and treated or not treated with antithrombotic drug/s (acetylsalicylic acid and/or either clopidogrel/ticlopidine/prasugrel and/or warfarin) exclusion criteria: * patients will not be excluded from the database if they fulfill inclusion criteria.

Keywords: clopidogrel aspirin percutaneous coronary intervention coronary stenting antiplatelet
efficacy of deep cervical flexor muscles training on neck pain, functional disability and muscle endurance in school teachers

Conditions: Neck Pain

Summary: neck pain (np) is a common work related disorder. teaching is one profession in which its prevalence is high. the daily job of a school teacher involves head down posture while reading, writing, etc., exposing them to risk of developing np. deep cervical flexor (dcf) muscles have been shown to have lower endurance in patients with cervical impairment which has been associated with disability. there is limited evidence that reports efficacy of dcf muscles training in occupational np. this study was done to see the effect of dcf muscles training using pressure biofeedback on pain, muscle endurance and functional disability in school teachers with np.

neck pain (np) is a common work related disorder. teaching is one profession in which its prevalence is high. the daily job of a school teacher involves head down posture while reading, writing, etc., exposing them to risk of developing np. deep cervical flexor (dcf) muscles have been shown to have lower endurance in patients with cervical impairment which has been associated with disability. there is limited evidence that reports efficacy of dcf muscles training in occupational np. this study was done to see the effect of dcf muscles training using pressure biofeedback on pain, muscle endurance and functional disability in school teachers with np. 65 teachers, aged between 25 to 45 years with experience of more than 5 years were agreed to participate in this study. subjects were randomly divided into two groups, experimental (eg) and control group (cg). in eg, subjects received dcf muscles training using pressure biofeedback in addition to conventional exercises for neck pain while in cg subjects received only conventional exercises. pain, muscle endurance and disability measured at day 0 (before treatment), day 14 and day 42 after treatment. endurance of dcf muscles was measured by ccf test using pressure biofeedback instrument, pain intensity was measured using nprs and functional disability was assessed using ndi questionnaire.

Eligibility criteria:
inclusion criteria: * experience of more than 5 years * neck pain score of more than 5 on numeric pain rating scale (nprs), mild to moderate disability score on neck disability index (ndi) and poor cranio-cervical flexion (ccf) test exclusion criteria: * any neurological sign or symptom, history of spinal surgery or if they were taking any treatment for their pain.
study to investigate the efficacy of symbicort® smart.

Conditions: Asthma

Summary: the primary objective of this study is to compare the efficacy of symbicort smart (symbicort turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with symbicort turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline turbuhaler 0.4 mg as needed, as asthma therapy


Eligibility criteria:
inclusion criteria: * diagnosis of asthma according to the global initiative for asthma guidelines (gina) 2007 with a documented history of at least 6 months duration. * reversible airway obstruction, defined as an increase in fev1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline turbuhaler * prescribed use of inhaled glucocorticoid steroid (gcs) (any brand) for at least 12 weeks. exclusion criteria: * respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks. * intake of oral, rectal or parenteral gcs within 4 weeks and/or depot parenteral gcs within 12 weeks.

Keywords: asthma symbicort turbuhaler
effect of pentoxifylline versus probiotic on preterm neonates with necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis

Summary: the aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.

this randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage i and stage ii nec. patients are allocated randomly into three groups (each included 25 neonates); group i (traditional therapy group) received antibiotics according to culture and sensitivity results, group ii (pentoxifylline group) received antibiotics and iv pentoxifylline at a dose of 30 mg/ kg given over 6 hours daily until discharge from the unit, and group iii (probiotics group) received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by ryle tube once daily until discharge. the serum level of high-mobility group box protein 1 (hmgb-1), intestinal fatty acid binding proteins (i-fabp), and total antioxidant capacity (tac) were measured on admission and at discharge.

Eligibility criteria:
inclusion criteria: * male and female preterm neonates less than 37 weeks gestational age * suffering from necrotizing enterocolitis (nec), according to modified bell's system which was first proposed by bell et al., 1978 as stage i (suspected), ii (proven) . * diagnosis of nec depends on; history, physical examination, laboratory and radiographic findings . * signs and symptoms of nec (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool * laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis. * anterior posterior abdominal radiograph is used for diagnosis in which pneomatosis intestinalis in stage ii nec exclusion criteria: * term and post term neonates * neonates with congenital infections * neonates with major congenital anomalies * neonates with stage iii nec